MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 EMSYS LNR AOX +4N 54X36; HIP IMPLANT : ACETABULAR LINER

Model Number	4722-54-436
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526); Unspecified Musculoskeletal problem (4535)
Date of Event	06/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical notification received for revision due to recurrent dislocations.Date of implant: (b)(6) 2023.Date of revision: (b)(6) 2023.(left hip).Treatment: head, liner, and cup were revised.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5 and h6 (clinical codes).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Medical records received.On (b)(6), 2023, the patient received a primary left direct anterior approach total hip arthroplasty, using depuy emphasys stem and cup, with ceramic on poly articulation, to address avascular necrosis of the left femoral head.There were no reported complications.On (b)(6), 2023, the patient was revised to address recurrent instability and multiple anterior hip dislocations.It was diagnosed as the cup being malpositioned with too much anteversion, and was more vertical than intended, allowing impingement in extension with leg external rotation.Both the emphasys cup and emphasys stem were found to already have a good fixation, though 2 months out from the implant date.The cup was explanted, along with the head, screws, and liner; the stem was retained.A pinnacle cup with two screws was placed, along with a 40mm liner and +12 mm 40mm head.There were no complications.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.Review of the x-rays evidence confirm the reported allegation.Based on the position of the femoral head regarding the cup, a dislocation event between the liner and the femoral head was able to be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: EMSYS LNR AOX +4N 54X36
• Common Device Name: HIP IMPLANT : ACETABULAR LINER
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17286748
• Report Number: 1818910-2023-13768
• Device Sequence Number: 6223880
• Product Code: LPH
• UDI-Device Identifier: 10603295500063
• UDI-Public: 10603295500063
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K221636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4722-54-436
• Device Catalogue Number: 472254436
• Device Lot Number: 3922485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 07/05/2023; 08/08/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 07/14/2023; 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELTA CER HEAD 12/14 36MM +5.; EMSYS SHL 3HOLE 54.; EMSYS STEM CLRD HO 8.; PINN CAN BONE SCREW 6.5MMX15MM.; PINN CAN BONE SCREW 6.5MMX35MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White